Saturday, January 29, 2011

Nestle invention? Osteoprotegerin in milk--human

"In the studies leading to the present invention, it has now surprisingly been found that in addition to its presence in e.g. the bone tissues, osteoprotegerin may also be found in human breast milk."

Surprise, surprise, surprise, I love surprises, don't you?

"The present invention pertains to osteoprotegerin obtainable from milk sources, in particular human and bovine milk."

Patent # 7749960 owned by Nestec, S.S. [Nestle] called, "Osteoprotegerin in milk," filed in October 2003. Inventors are Karine Vidal, Peter Van Den Broek, Elizabeth Offord Cavin, and Anne Donnet-Hughes. This invention is to be used in the treatment of disorders associated with bone remodeling or immune disorders. The list of disorders is long and interesting: "allergy, autoimmunity, inflammatory bowel disease, systemic autoimmune conditions, dysregulation of cell proliferation and apoptosis and immunopathological conditions of the skin, the oral cavity, the gastrointestinal, urogenital or respiratory tracts." Also, " disorders associated with prematurity and/or low birth weight."

The patent goes on to state, "In particular individuals, such as newborns, require osteoprotegerin for the development of bone material and/or the immune system..." Nestle will be providing a pharmaceutical composition, a food material, or an enteral composition made from this material--osteoprotegerin from human milk...

The patent is focused on human milk not bovine milk for obtaining osteoprotegerin. "Human breast milk samples (10-60ml) from healthy mothers were collected up to 17 days post-partum underster sterile conditions." Who supplied Nestle with breastmilk? Did breastfeeding mothers understand who their milk was going to? Were they paid or did they just donate it?

The patent goes on about the cloning of human milk osteoprotegerin in yeast-Yarrowia lipolytica. Their first claim, " A food material comprising an osteoprotegerin isolated from human or bovine milk or colostrum." They have a number of claims in this patent for methods of making the food material derived from human and bovine osteoprotegerin (although I see nothing in patent related to bovine milk). But their first claim is for the MATERIAL they have isolated from human milk. Ownership of human milk cells by Nestle, should we be surprised? Should we be surprised that preterm infants have to have fortified human milk because supposedly they don't get enough calcium? Who owns the research and why do we believe that research?
Copyright 2011 Valerie W. McClain

Tuesday, January 25, 2011

Heart disease

My Dad died a few years ago from a stroke after a long struggle with heart disease. In the late "80's he had a heart attack in the ER and survived. The medical staff said he survived because of a new drug they called Pac Man. Much later I would find out that it was a drug that had been genetically engineered to dissolve clots in the arteries. (called TPA, tissue plasminogen activator, by Genentech) He went on to have a quadruple bypass and did rather well for awhile. At some point they gave him a pacemaker and he gradually spent more and more time at doctors' offices to his increasing dismay and distress. He refused alot of procedures and his heart doctor wrote him a letter describing him as non-compliant. My Dad's interpretation of this letter was that the doctor was refusing him as a patient because he won't do what he was told. My Dad was 83 years old. He never talked much about his by-pass surgery but he let us all know that he would never, ever do THAT again. By-pass surgery usually holds up for an average of 12 or 13 years and the doc felt it was time to do it again. My Dad thought otherwise. Yep, that was my Dad, feisty, even as his body gradually slowed down. In 2009, he became ill and went to the ER, was admitted to intensive care. He contracted MRSA and was put into isolation where he had to be restrained because he started to flip out. I think it was the drugs, the isolation, and a disease that limits oxygen to the brain that caused him to flip out. It was horrifying to be a witness to what I perceived as brutal medical procedures to my father. My Dad had never wanted extraordinary means to keep him alive. He fought the pic lines and the IVs. He refused to eat. He lost an enormous amount of weight. The family literally had to fight in the hallways with doctors and nurses who believed that every drug , every bit of medical technology must be used to keep him alive. How dare the family decide for this man, that he would rather not have all this done. How dare the family view this as torture of a man who had lived an active, caring life, and had always chosen a path of less medical interventions. I felt like he was a prisoner of the hospital system and getting him to hospice was a battle that seemed so unnecessary and emotionally wrenching. I have memories of standing in the hospital hallway in tears while a physician's assistant and a nurse questioned my motives for demanding that the hospital release my Dad to hospice.

His last days in hospice were a blessing. He literally got better, he started to eat and respond like himself. On the day, I was to take him home because he got so much better, he had a stroke. He died a few days later in peace. It was two months of hospitalization, with a brief interval of a nursing home. I would never wish this situation on anyone. But in walking the hallways of the hospital and nursing homes, I saw many families going through the same journey. Heart disease impacts many families. The World Health Organization states it is the leading cause of death in the world. It is the leading cause of death in the USA. The CDC states that in 2010, heart disease will cost the US $316.4 billion.

What do we know about heart disease? What is the relationship between the foods we eat and our lifestyles that cause so many of us to suffer the same disease? Heart disease just doesn't happen overnight. And we now know that what we eat, how much we eat, our activity levels, and our emotional well-being impact whether or not we acquire this disease. Yet what seems surprising to me is that there is so little public discussion of how infant feeding impacts heart and circulatory health. How does the decision to use infant formula rather than breastfeeding impact a infant's long term heart health?

There are of course, some inventions/patents in which researchers have some ideas about preventing heart disease through the use of altered cow's milk or human milk components (genetically engineered). For example, patent #7863002 called "Breeding and milking cows for milk free of .beta.-casein A.sup.1" filed in 2009 by the A2 Corporation Limited of New Zealand. They are creating a milk free of the .beta.-casein A.sup.1 protein. "Such milk is useful for the prevention or treatment of coronary heart disease." I gather that for years many infants have gotten cow's milk that has the beta-casein that is implicated in coronary heart disease or so the research implicates. We know that beta-casein from human milk is different. Is this company using a beta-casein that is more similar to human milk? Not sure, but from statements from other companies, one might suspect that they might be attempting to create a beta-casein similiar to human beta casein. According to patent # 5739407 called, "Human .beta.-casein, process for producing it and use, thereof," filed in 1993 and owned by Symbicom aktiebolag of Sweden, "The main use of the recombinant human .beta.-casein is a constituent of infant formula." Ventria Biosciene in patent #7718851 filed in 2008 states, "In addition it has been reported that breast-fed infants have a different growth pattern than formula-fed infants(Dewey et al., 1992; Dewey et al., 1993), and epidemiological studies that they have a lower incidence of chronic diseases, such as diabetes and coronary heart disease."
Agennix Inc. of Houston in patent # 7026295 filed in 2003 states, "Lactoferrin in the reduction of circulating cholesterol, vascular inflammation, artherosclerosis and cardiovascular disease..." Agennix manufactures recombinant human lactoferrin (human milk component genetically engineered) and is doing clinical studies on the use of human lactoferrin for wound management. In patent # 6455687 called "Human lactoferrin" owned by FerroDynamics and dated 2001 they state, "Lactoferrin can be used to sequester iron implicated in heart disease. By sequestering iron that promotes the oxidation of lipids, which when oxidized can clog arteries, lactoferrin can aid in reducing heart attacks."
How we are fed as infants will either increase or decrease our risk of heart disease. I do not believe my Dad was breastfed as an infant or if he was it was in a very limited manner. It would seem to me that those billions of dollars we are spending on heart disease could be decreased, if we had a black box label on infant formula and included heart disease as one of the many risks of infant formula.
Copyright 2011 Valerie W. McClain

Wednesday, January 19, 2011

A black box label on infant formula

"You can't make me breastfeed!!" The woman screamed those words into our WIC office from the hallway. She felt that the WIC breastfeeding promotion was an ultimatum. I am not sure why she came to that conclusion. No one in our office had seen her before. So it seemed that the rumor-mill among the clients had changed the promotion theme to an ultimatum. I don't remember what happened after that, what we said or did. But I know we felt like we were walking on "eggshells." How does one turn society around when that society is walking down a self-destructive path? Do we force the issue? And we all know that force/power may work overtly but that human nature does not respond well to being told what to do. We are a creature that yearns to be free. No one responds well to being told what to do or how to think. Thus, a government program that is about promoting breastfeeding becomes in the minds of some people another vestige of the government's power trip. I wonder now, if women who feel so strongly against breastfeeding, were to understand the underpinning of the infant formula industry; might they change their minds? The research has and is creating a formula to imitate human milk. Genetic engineering has created the open door to creating "novel" human milk components to be placed in baby formulas. So moms, if ya don't breastfeed, then by golly our scientists will make sure your baby gets the synthetic version. Yet, where is the safety data on these gene constructs placed in formulas for our most vulnerable population? Not anywhere that I can see because there is this belief perpetuated by the FDA that a genetically engineered organism is identical to the real thing. Thus there is no need to look at safety issues. So our society is allowing our infants to be the lab rats, the guinea pigs to a massive scientific experiment. No need to label the ingredients that are genetically engineered. Parents are left in the dark about what they are feeding their babies and their children.
After reading so many patents on infant formula and their use of these "synthetic" human milk components, I find myself very troubled. Over the years, there is a repeat pattern that appears in these patents. There is a problem with infant formula and we need to reinvent the formula--repeated over and over again. So how much damage has been done over the years? What is the financial cost, not only in terms of the product itself, but in the medical bills and hospitalizations caused by a product that damages the gut, is sometimes contaminated with toxins and pathogens that kill? Now that the industry seeks to imitate human milk's healthful benefits, and no longer considers its product just a food, shouldn't this product be considered a drug in need of regulation? How many products on the marketplace that can cause death, acute illness, and long-term health problems stay on the market without a listing of those possibilities for the consumers? Shouldn't parents at least see on an infant formula can a black box label of the risks to their infant: diarrhea, allergies, short gut, cancer, diabetes, heart disease, obesity, decreased learning abilities, etc. All these serious health effects are mentioned in the infant formula patents. Why do we believe that infant formula is a benign product?

a "NOVEL" infant formula
Patent #78675411, "Compositions & methods of formulation for enteral formulas containing sialic acid" owned by Mead Johnson filed in 2003

"While human breast milk contains substantial amounts of sialic acid, most infant formulas contain less than 25% of the sialic acid found in colostrum. Moreover, 70% of the sialic acid in formulas is glycoprotein-bound, unlike human breast milk in which 75% of sialic acid is bound to oligosaccharides. See Heine, W., et al., Monatsschr Kinderheilkd 141:946-50 (1993), Wang, B., et al., Am J Clin Nutr 74:510-5 (2001), and Nakano, T., et al, Acta Paediatr Taiwan 42:11-17 (2001). Not surprisingly, the accumulation of sialic acid by breast-fed infants is generally higher than for formula-fed infants. See Wang, B., et al., J Pediatr 138:914-6 (2001). Evidence suggests that N-acetyineuraminic acid (NANA, or sialic acid) is important in the development and function of the neonatal brain where it is a major component of gangliosides. See Carlson, S. E., Am J Clin Nutr 41:720-6 (1985), Morgan, B. and Winnick, M., J Nutr 110:416-24 (1980), Svennerholm, L., et al., Biochim Biophys Acta 1005:109-17 (1989), and Wang, B., et al., Comp Biochem Physiol A Mol Integr Physiol 435-9 (1998). Therefore, infants fed commercial formulas may not be acquiring sufficient quantities of a nutrient important for early development. "

A problem with the development and function of the neonatal brain? I thought DHA and ARA was suppose to resolve that issue? So add brain dysfunction to the list of risks? Looks like they have scientific research to back up their claims but will parents ever understand the risks?
Copyright 2011 Valerie W. McClain

Saturday, January 15, 2011

Why is breastfeeding so damn difficult?

Pyne's laughter filled the house of my mother-in-law. She looked at me and continued to laugh. "You want to do what?" "You want to help women to breastfeed?" And then the laughter started up again, a very infectious laughter. I found myself laughing. Was I laughing at myself and my pretentiousness? Or was it her laughter that surrounded me with the joy of her world. She wasn't laughing at me but as she explained to me the idea of teaching/helping a woman breastfeed was unheard of in Liberia. Pyne had immigrated from Liberia to New York City to escape the violence of her country. She was a beautiful woman. She was tall and elegant with high cheekbones, sparkling brown eyes, and skin a velvety brown. Pyne tried to explain to me that women just know breastfeeding, they don't have to be taught. Like walking and talking, breastfeeding is just known. I tried explaining the US reality of women unable to breastfeed, of all the difficulties that women encountered. And she just stared at me and shook her head in wonder. Culture shock for both of us. In the short time that I got to know Pyne she shared her knowledge of cooking plaintain-delicious. She showed my young daughters and I how to wrap on our bodies a simple dress, a Fanti. She talked of her home in Liberia, of encountering a Black Mambo snake on the way to school. She laughed often and her stories enthralled us all. That was years ago.
I still relive the laughter but also the clash of our cultures, particularly regarding our views on breastfeeding. She thought I was ridiculous to think that breastfeeding was this difficult behavior. And I just couldn't get over the idea that some cultures view breastfeeding like walking and talking, it just happens because that is what humans do.
How did our culture get so wacked, so out of balance that breastfeeding requires expensive gadgets (breast pumps), drugs, and some paid expert to get it to work? What is it about our environment that short circuits breastfeeding? I still feel the shock of having Pyne think I was ridiculous for thinking breastfeeding difficult or that women might need assistance to breastfeed. Yet, now 25 years later, I see only too well that whether breastfeeding succeeds or fails is very much tied to a mother's perception of reality. If her reality, her faith, her knowledge is steeped in technology; it will be incredibly difficult for her to take a leap of faith and believe that breastfeeding is like walking and talking.
From the moment of birth, we are creatures of imitation. We learn by imitating. If breastfeeding is a hidden part of life, then women will find it a very difficult to imitate that behavior. If living becomes so out of step with nature, then our faith becomes vested in our technological society. We cannot trust our bodies to function correctly and that belief becomes a self-fulfilling prophecy.
Years ago I did a home visit with a mom who was employed in the medical field.
She told me she didn't have enough milk (a theme exploited by the infant formula industry through marketing). During our two-hour home visit, she nursed her baby to sleep, pumped 4 ounces of milk with an electric pump, and then hand expressed 2 ounces of milk. I told her that it sure looked like she had plenty of milk. She had been thinking she needed to use infant formula. Her baby was gaining weight and healthy. But her perception was that breastfeeding wasn't working. Seeing all the milk, helped her realize that the milk was there. As someone in the medical field, she needed numbers and needed to see the milk. Once she saw this, she was able to continue breastfeeding without needing the infant formula. And she went back to her job in the hospital and was able to provide her young baby with her expressed breastmilk.
Is breastfeeding difficult or are mother's perceptions of breastfeeding the difficulty?

Back to the reality of the pharmaceutical industry...another patent using a human milk component to prevent and treat cancer. Called, "Cripto tumour polypeptide," patent #7439320 owned by GlaxoSmithKline Biologicals, filed in 2001. Cripto is found in mammary epithelial cells. These cells are part of human milk.
Copyright 2011 Valerie W. McClain

Thursday, January 13, 2011

Choice: the conundrum of infant feeding

Should a society let women have choice in how an infant is fed, when that society understands the enormous health consequences of deciding to use artificial milks? There are people who believe that women, particularly women in poverty or women in developing nations must be made to breastfeed. The infant should not be made to suffer because the mother hasn't enough sense to breastfeed. Governments should not have to pay for the infant formula and the subsequent health problems resulting from infant formula use. A few years ago I spoke at a gathering explaining the WIC Program (at that time I was employed by the local WIC Program) and its promotion of breastfeeding. When I had finished speaking, a well-dressed woman came up to talk to me. She wanted to let me know what a good thing I was doing. Which of course, made me feel good, but then she launched into a rant about how women on welfare must be made to breastfeed or be kicked off the Program. I found myself shocked. Shocked that my speech triggered those kind of thoughts. How does one make a woman breastfeed? Do you send an armed guard to watch her every move. Women on public assistance already believe (with some justification) that the government invades their privacy. So the well-off people of the world want people like myself to control women on public assistance. Well, I am not the breastfeeding police, nor are the many who serve these Programs. Should the issue be about women's choice between formula feeding or breastfeeding? Or rather is the real issue a society that creates/markets values that subvert breastfeeding? Our society values the employed mother, because those that don't work have less value in our money-driven society. How do you put a price on the work that women do within the home and in bringing up their children? Despite our supposed female liberation, most women are the caretakers of the children and the home. And now society has determined that we also must be employed to be of value to society. I did home visits to WIC breastfeeding mothers and became intrigued by what this liberation means to young resource-deprived woman. She wants to breastfeed, can't ask for breaks at her place of employment because low paying jobs often have young male supervisors. Most young women refuse to consider discussing their need to pump during employment with a young male supervisor. Often the kind of job these young women had didn't have scheduled breaks: work when its busy, take a break when its slow. At home visits I was taken aback by the fact that often the father of the baby (boyfriend, maybe not father) was unemployed and seemed uninterested in helping with the baby. One shouldn't generalize situations but I remember thinking if this is young people's version of the sexual revolution and women's liberation who in their right mind would want it? Or is it just a woman trapped by a society that has concocted rules that punish single women for having babies? Back at that time, the Florida legislature required that women who received public assistance needed to be employed at 2 months postpartum or lose all benefits. Most of the mothers I met were scrambling to go back to work at 2 weeks postpartum.
Anyway, I found that employment is a risk factor for weaning and weaning early. There is clearly a lack of support and funding to help women in poverty mother their babies. So in these situations are women making a choice or has government programs created the need for the decision to use artificial baby milks?
How do women make a choice to not breastfeed? The mother may decide not to breastfeed because she thinks breastfeeding is "icky." but her body does not know that she has made that choice. Thus, after birth the mother's mammary glands go into full production and she has to actively suppress lactation. What are the ramifications of actively suppressing lactation? She may face a higher risk of breast cancer than the woman who breastfeeds. But we know that people make choices about their biology. We can decide not to walk, to let our legs become useless appendages. But most people would think that pretty weird decision to make, and an enormous burden to their family and society. Who wants to be crippled in life? The same can be said about breastfeeding. We can make the choice to not breastfeed. We can deny our biology. But the ramifications to families and to society run deep, when we decide against using our bodies in the way they function. Handicapped? Yes. But would I want breastfeeding to be mandatory? No, because life ultimately must be lived by the mother not the government, not society. No one can make someone breastfeed her baby, just as no one can make a baby breastfeed. It takes willingness and education of the mother, and most of all a society supportive of breastfeeding. Choice is the illusion.

Another interesting patent regarding the use of lactalbumin (from human milk or a recombinant) to treat bacterial infections and cancer. Patent #7524932 called, "Lactalbumin production process," invented by Catharina Svanborg and owned by Nya HAMLET Pharma AB of Denmark filed in 2006 (same patent filed in 1998 by same inventors, same title, only owned by HAMLET Pharma AB-Sweden)

"A fraction from human milk containing an oligomeric complex, described as multimeric .alpha.-lactalbumin or MAL has previously been reported which has different biological properties to the monomeric form. In particular, the oligomeric complex is reported as having therapeutic applications both in the field of antibiotic (WO96/04929) and cancer therapy (A. H{dot over (a)}kansson et al., Proc. Natl. Acad. Sci USA, (1995) 92, 8064-8068). In particular, the oligomeric form of .alpha.-lactalbumin induces apoptotic cell death in cancer cells and immature cells, but not in healthy cells. These observations suggested that the protein acquires novel biological properties after conformational switching. "

Hm, a human milk component that works like an antibiotic and cancer therapy....pretty darn the choice is between the substance that works like an antibiotic and kills cancer cells versus the substance that continues to have adverse effects? Choice????
Copyright 2011 Valerie W. McClain

Wednesday, January 12, 2011

Diabetes, adverse effect of infant formula

Our culture has a premise that is the basis of the infant formula industry. Women can't breastfeed or they don't want to breastfeed. Throughout patents on infant formula this premise is the reason for creating a better, safer infant formula. Yet who examines the premise? Who says, why don't women want to breastfeed? Why is breastfeeding so difficult nowadays? Well, we could suggest that infant feeding is now a choice to all women, not just a select few wealthy women. An industry stepped in and created choice; to free women from the burden of their biology. Free at last, free at last, thank god for men (actually women are inventors, too) and their inventions. Choice is not what nature intended. Choice is what the corporate world wants because it makes money. Of course, when we circumvent nature there are biological consequences to the mother and her baby, and to society at large. Those consequences are sicker children, sicker mothers (more breast and ovarian cancers). Higher need for artificial birth control measures, since exclusive breastfeeding prevents ovulation. So we are talking higher health costs. Higher health costs benefit who? The pharmaceutical industry benefits because there is a need for more drugs, more testing, more devices. Choice means mothers can work and be free of the burden of childcare. They can work to pay the babysitter, one of the ironies for women whose jobs pay minimum wage. Of course children housed in daycare are sicker, so that is another burden for families. But sicker children mean that we must have more drugs and more vaccines. The logic of the current ideology of female liberation seems rather horrifying when one looks at the stark reality. Actually, if one takes a look at the patents on human milk components or on infant formula, one is in awe of what our science seems to know regarding human milk. It has the power to heal, to effect the DNA. It is a food, a medicine, a vaccination. Yet so few people seem to know how remarkable this substance is instead we read and hear the words, "yucky" or "grouse" when people discuss breastmilk or breastfeeding.
Here is another patent to ponder. Patent # 6365177 called "Insulin supplemented infant formula," owned by Insotech (Maabarot, Israel) inventor Naim Shehadeh filed in 2002. Remember that here in the US, the Breastfeeding Ad Campaign in 2003 was watered down because the infant formula industry and the AAP believed that there was not enough research on the risks of infant formula. From the patent:

"Many studies show that type I diabetes is related to cow's milk consumption and neonatal feeding practices (2,10). In the case-control studies (including a study conducted in the Juvenile Diabetes Unit of the Rambam Medical Center, Haifa, Israel), patients with type I diabetes were more likely to have been breast-fed for less than 3 months and to have been exposed to cow's milk proteins before 3 months of age (3). Moreover, the immune system of patients with IDDM recognizes cow's milk proteins, as demonstrated by antibodies assays and lymphocytes activity tests (11). These data emphasize the importance of diet and orally administered proteins on the development of autoimmune diabetes. "

This has become a product owned by Israel's Nutrinia called InsuMeal (company owned by New Generation Technologies and Maabarot Products (Materna infant formula). It is a bioactive insulin. "Insulin is 100 times more concentrated in the first milk a mother gives her baby than in the blood. Nature must have a reason for enriching the first milk and helping the newborn get over the shock of the first 24 hours." quote from Shehadeh at Nutrinia dated 2007

Materna Labs, maker of infant formula, controlled by Maaborat Products was acquired by Nestle in 2010. I don't know if the bioactive insulin was put into infant formula--it was being tested on premature babies back in 2007. But if one believes that industry knows that infant formula increases the risk of diabetes, should we thank that industry for creating something better? Or should we be troubled by what we didn't know before the industry figured out there was a problem? Choice costs money and lives. Should we question choice or go on creating, reformulating infant formula because of its adverse effects?
Copyright 2010 Valerie W. McClain

Tuesday, January 11, 2011

Inventing a better infant formula to reduce adverse effects

"It has been demonstrated that breast-fed newborns have a lower incidence of intestinal infections, intestinal inflammatory conditions, lower incidence of respiratory infections and later in life, less allergic disease."

Patent #723078 owned by Nestec SA [Nestle] entitled "Soluble toll-like receptor," filed in 2002

Say what?? Wait a minute, wasn't the US Breastfeeding Ad Campaign in 2003 watered down because the infant formula industry and the AAP (American Academy of Pediatrics) expressed concern about the validity of the science regarding the risks of infant formula? Yet, Nestle within a patent is explaining why they need to improve infant formula. Nestle found a soluble toll-like receptor. Although we, breastfeeding advocates, may choke upon the following statement in this patent, "In still a further embodiment, the polypeptide according to the invention is derived from human breast milk or identical to a milk derived variant." So what conclusion can we draw from this? Publicly, in the US the science on risks of infant formula are not open for discussion. Privately, the industry will own and monopolize off those risks to improve infant formula. Thus public discussions about risks of infant formula in the USA are "off the table." Instead the discussions are reconfigured and stated as the risks of not breastfeeding. Didn't know there were risks to breastfeedings. Oh yeah, like the risks of walking or talking, biology is scary. Heaven forbid we make clear statements or look at patents to understand what the infant formula industry knows that the public is not allowed to know. Yes, that is what patenting is about, monopolization of "invention" which is ultimately the monopolization of knowledge.
Let's leave Nestle for a moment and go on to other infant formula companies (yes, other companies do exist besides Nestle). Lets look at N.V Nutricia of the Netherlands. This is another infant formula company in Europe. Their recent US patent application called, "Immune stimulatory infant nutrition." (application # 20100136134) They state, "The composition reduces--among others--the risks attached to feeding whey dominant infant formula." and "Human milk has for example been shown that human milk protects against infection and allergies."
Or better yet lets look at a US infant formula company, Mead Johnson and their statements in patent #7862808 called, "Method for preventing or treating respiratory infections and acute otitis media in infant using Lactobacillus rhamnosus LGG and Bifdobacterium lactis B6-12,"

"In a meta-analysis of data from multiple studies, results indicate that breastfeeding may have a positive effect on the frequency of both infant respiratory infection and AOM.[acute otitis media] Specifically, one study indicated that the feeding of many currently available infant formulas may be associated with a 3.6-fold increase in risk of infant hospitalization for respiratory infection when compared to at least four months of exclusive breastfeeding. Bachrach, V., et al., Arch. Pediatr. Adolesc. Med. 57:237-43 (2003). Additionally, infants who are breastfed have been shown to have significantly fewer (about 50%) episodes of AOM than do infants who are exclusively formula-fed. Duffy, et al., Pediatr. 100(4):E7 (1997). These differences may be attributed to the fact that human milk promotes the growth of beneficial bacteria such as Lactobacilli and Bifidobacteria. Duffy, et al., Dig. Dis. Sci. 44(8):1499-1505 (1999). "
Wow, I think they are saying that human milk is probiotic. Let me understand why breastfed babies are being given probiotics? They are deficient...deficient because they aren't breastfed enough?? Or maybe cause mothers don't know where probiotics comes from?
Then there is formula maker Wyeth LLC (which is now part of Pfizer). Their patent filed in 2005 is called, "Methods for reducing adverse effects of feeding formula to infants," patent # 7651716. "In some embodiments the administration of the infant formula compositions of the present invention reduces or eliminated side effects." The side effects are listed as, "eructation, constipation, gastroesophogel reflux disease, flatulence, abdominal pain, vomiting, diarrhea and regurgitation."
So the continual patenting of infant formula is because there are adverse effects in infants who are fed artificial milks. The politics of infant feeding mean that in the US we will continue to believe that there are no risks to infant formula in developed countries, only risks in developing nations. What should be shocking and galvanizing to the health care community is that in order to reduce those adverse effects, the infant formula industry uses human milk components (in most cases genetically engineered) to reduce the adverse effects. Meanwhile, the US public is kept in the dark and will continue to buy a product that has adverse effects, RISKS. Kinda reminds me of the Tobacco Industry. Hide the real research, advertise like crazy, and give great gifts to the medical community.
Copyright 2011 Valerie W. McClain

Thursday, January 6, 2011

Humanized milk: cloning to create a better infant formula

Remember Dolly, the sheep, the first mammal to be cloned from an adult somatic cell? She was cloned at the Roslin Institute/PPL Therapeutics in Scotland in 1996. PPL Therapeutics was also located in Blacksburg, Virginia. The donor cell was taken from the mammary gland of a different breed of sheep. Remember, mammary gland. Remember that all mammary glands have totipotent stem cells. The US public is quite oblivious to our technological advances in creating a better infant formula. I wrote and talked about cloning in 2000. Back then I wrote about transgenic herds around the world. Not too many people believed me. In fact, I got the feeling they thought I was jumping to conclusions. Now that the FDA has approved cloned milk and meat for US consumption, one would think the public would understand that cloning is not something that will happen in the future but has already happened...some time ago. FDA approval has come about because these products were already being consumed by the public. The same thing happened with genetically engineered crops. The US public has been eating it for some time without knowing about it. Who needs labels on foods? I imagine the FDA believes that Americans don't read labels anyway and don't care where their food comes from. I don't believe that but why else would there be such massive deception about our food? Well, yeah, maybe the regulators are just part and parcel of the corporate system that is ramming this technology down our throats?
I guess the shocking part is that this system is so willing to make guinea pigs of our babies. And the ideology is that women can't and don't want to breastfeed so we are going to invent a better infant formula. No questions are asked about whether the reason for not breastfeeding is partially created by corporate marketing of products. Or that birthing has become a medical technological nightmare which impacts breastfeeding. Or that US society creates enormous financial hardships on women who have babies. Unless a woman is financially well-off, the burden of earning a living means abandonment of her baby to other caregivers.
So here we are at the Edge, a society whose brightest and best are creating a better infant formula. What does that mean? Genetic engineering. Cloned milks.
In past posts, I wrote about BSSL, bile salt-stimulated lipase, a human milk enzyme not found in cow's milk and because it is an enzyme, heat destroys most of it. In a article written in the Biology of Reproduction authored by researchers from PPL Therapeutics of Roslin, UK and Blacksburg, Virgina in 2002,
"The transgene used in these studies codes for a potentially therapeutic protein, bile salt-stimulated lipase (BSSL). BSSL is an orally active enzymatic protein that is normally produced by the human pancrease and is present in human breast milk and that helps break down fats to make them more available for use by the digestive system. This protein has significant potential for use in replacement therapy for patients with pancreatic insufficiency (including cystic fibrosis patients) and for premature infants who do not receive human breast milk."

PPL Therapeutics has a patent filed in January 1995 called, ".alpha.-lactalbumin gene constructs," patent # 5852224.
"The present invention utilizes genetic engineering techniques to prepare non-human transgenic mammals that express human .alpha.-lactalbumin in their milk at a concentration of 2 mg/ml or greater."

A patent by Pharming B.V. of Leiden, Netherlands filed in 1998 called "Production of recombinant polypeptides by bovine species and transgenic methods," patent #6066725 states, "The invention also includes transgenic bovine species capable of producing recombinant polypeptides in transgenic milk as well as the milk from such transgenic bovine species and food formulations containing one or more recombinant polypeptides."
Old patents, dated from the 90's, the companies have been sold and bought. Has this technology ended? Who is invested in making a better infant formula? Is it just the infant formula/pharmaceutical industries? Back in 1991, The United States of America as represented by the Secretary of (Washington, DC) owned a patent called, "Preparation of simulated human milk protein by low temperature microfiltration, " patent #5169666 stated, "Breast feeding is generally recognized as the preferred method of feeding human infants, however, when for a variety of reasons mother's milk is unavailable, infant formulas based on cow's milk are used. The use of modified or "humanized" bovine milk in infant formulas designed to simulate human milk as a substitute or supplement, has long been a subject of continuing research."
The patent is interesting to read because of the manipulations done to cow's milk to make it more human. I am fascinated that the US Government was so involved in developing a better infant formula. Patenting is monopolization, why is the government doing this? Simple I suppose... to make money. That was back in 1991 and we have come a long way to create a better infant formula, rather than filtration or ultrafiltration or microfiltration, we now take human genes and place those human milk component genes into cows. Is the US Governement still financially involved in creating a better infant formula?
Copyright 2011 Valerie W. McClain